Monthly Archives: June 2022

A call centre operator plagued by such virulent eczema she was left balding, bedbound and slept in a balaclava to stop her oozing face from sticking to the pillow says a life-changing 9 cream cleared her skin overnight.

While Kimberley Reardon, 30, suffered with mild baby eczema until she was three-years-old, it did not flare-up again until her teens and it was only in her 20s that her catastrophic problems began and she was covered from head-to-toe in red raw patches of the dry, flaking skin condition.

For the next decade, her eczema frequently developed into painful, weeping sores and saw Kimberley trying numerous steroid creams.

However, the treatements would work only briefly, before the angry conditionreturned with such vigour she would be unable to move without her skin weeping or peeling.

After several hospitalisations, infections and periods of being bedbound, by March 2022 Kimberley, who lives with her boyfriend of 12 years, healthcare assistant, Scott Hannah, 31, had lost hope only for her mum to stumble upon 8.99 Balmonds Skin Salvation cream that practically cleared her skin overnight.

Kimberley, of Hamilton, South Lanarkshire, Scotland, said: I was exhausted and hopeless. It felt like it was never ending.

I had spent nearly 10 years in chronic pain and itwas an achievement for me to just get myself washed and dressed in the morning.

I have tried so many creams that dont work, so when my mum suggested I tried this one, I was very sceptical about it working.

But, when I woke up the next day, my face was almost clear it was unbelievable.

Kimberley Reardon, 30, in May 2018, before her skin spiraled out of control (Collect/PA Real Life)

Despite suffering with mild baby eczema, her skin complaints only really started in her teens.

She said: My parents would usually use a cream on me as a baby which would work, but then the eczema appeared again when I was going through exams at 15.

It started on my back and spread to the creases in my elbows, with patches of redness.

It bothered me, but it hadnt spread to my face at that point, so I could just hide it.

Kimberleys eczema covering her face and neck in March 2020 (Collect/PA Real Life)

To ease the eczema, Kimberley was prescribed a steroid cream which was steadily increased in dosage to match her increasing flare ups. But hitting 20, the steroid creams seemed to stop working and during the next three years her condition intensified and spread to her face.

Kimberley Reardon, 30, and Scott Hannah, 31, have been together for 12 years (Collect/PA Real Life)

She said: I was studying for my social sciences degree at university, working part-time in a call centre and caring for my grandad because he was poorly and he had pneumonia.

Stress was definitely a trigger for my eczema, which went from some scaly patches to covering my whole body in red, inflamed dry skin that was just falling off my face.

Kimberleys arm was red raw in December 2020 (Collect/PA Real Life)

She added: My arms looked like red sleeves, while my legs were also covered and my neck was incredibly sore.

It was unmanageable. I was trying to use creams, emollients and moisturisers and wrapping myself in bandages, to try and help them to be absorbed into my skin.

Diagnosed with severe and widespread erythema at 23 a rash caused by injured or inflamed blood capillaries, usually in response to a drug, disease or infection Kimberleys skin became worse and worse.

Kimberley Reardon, 30, with makeup on for the first time in years (Collect/PA Real Life)

I wasnt functioning at all, I was exhausted, she said.

I felt ruined, like my body was fighting against me constantly.

It felt like I had severe sunburn over my whole body as if it was burning me from the inside out.

Kimberleys hand raw and peeling earlier this year, in April 2022 (Collect/PA Real Life)

After years fighting the eczema without success, Kimberley felt depressed, although she still tried to go out and have a normal life.

She said: I remember putting foundation on the top of my hands to try and cover the red patches,

One time a woman saw my hand when I pushed the lift button at work and she said, Oh! Have you been burnt? I felt so embarrassed.

I started wearing foundation to try and cover the patches, as well as long sleeves and big jumpers, even in the summer to try and hide my skin.

Kimberleys skin flaking and peeling in September 2020 (Collect/PA Real Life)

I felt so out of control of my skin that I started to micromanage everything else that I could to compensate.

Even though it hurt to move, I was hoovering six times a day to clear my skin up.

I was in so much pain, but I became obsessive about things.

I couldnt leave dishes out and I became totally over the top with cleaning and constantly checking my money, even though I knew I could pay my bills.

Kimberley Reardon, 30, with her boyfriend, Scott Hannah, 31(Collect/PA Real Life)

In 2018, Kimberleys skin condition became so bad she was hospitalised.

She said: My mum took one look at me and was horrified.

Ninety five per cent of my body was covered in red, swollen and burning skin.

I was losing too much fluid through my skin, where I was oozing out.

Kimberley Reardon on March 13, 2022 (Collect/PA Real Life)

She added: And the doctors said I was critically ill. My skin was so weak and I wasnt able to regulate my temperature.

After two weeks on an IV drip in hospital, Kimberley was placed on immunosuppressants and five months of oral steroids, to try and tame her excruciating eczema.

And when 2020 hit, she found herself completely bedbound.

Kimberley Reardon, 30, in March 2018, covering her red hands in foundation (Collect/PA Real Life)

She said: From January to March, my skin was the worst it had even been.

Doctors doubled my doses of immunosuppressants but nothing worked.

I had to have spare sheets to change and lie on every few hours. I was ruining the bed sheets where my skin was so flaky and oozy.

I was spending hours lying in really hot baths, because they seemed to be the only thing that relieved my skin, although it would be worse when I got out.

Kimberley said it was a blessing working from home in lockdown because of the pain and fear of judgement (Collect/PA Real Life)

She added: I was crying constantly and I didnt look like me at all.

I would think, Am I ever going to get better, is this it?'

When the March 2020 lockdown came in, it was a saving grace for Kimberley, as she was able to better manage her pain while she was working from home.

Prescribed new immunosuppressants, her skin briefly cleared but even then, she was plagued with a litany of other side effects.

Kimberley Reardon, 30, struggled immensely with her skin in 2020 (Collect/PA Real Life)

My skin was amazing but I was having other problems, she said.I was vomiting all the time, sleeping all the time and I couldnt keep food down.

Then, in July 2020, her skin flared up again so severely that she was hospitalised once more and signed off work for five months.

She said: I was bitten by an insect, which caused an abscess and cellulitis, a bacterial skin infection, because I had no immunity.

Kimberley trying to get through the pain in August 2020(Collect/PA Real Life)

Kimberley added: I was in hospital for two weeks on a drip again and antibiotics, followed by another three weeks of antibiotics at home.

I was bedbound, I barely got up and my poor boyfriend was carrying me to the toilet and running the bath for me.

I barely got changed, as it would take me hours to get dressed.

I lost my hair from the stress on my head, eyebrows and even my eyelashes.

And I didnt sleep for months because of the pain.

I was bedbound, I barely got up and my poor boyfriend was carrying me to the toilet and running the bath for me

Kimberley tried to go cold turkey without any medication to see if her body could heal itself, but nothing seemed to improve.

My face was covered, my body was covered, she said.

My boyfriend had to care for me, I couldnt do anything.

I spent my days in pain, just watching TV, or I sat in the bath for hours for some relief.

The worst thing for me was feeling like such a burden.

Kimberley Reardon, 30, with her clear skin in May 2022 (Collect/PA Real Life)

In a bid to help moisturising remedies to be absorbed and to stop her skin from weeping on everything, Kimberley would wrap herself up like a parcel.

She said: I was living in my eczema jammies, with long sleeves and long legs.

I would use bandages for my neck and my mum even got me a balaclava to sleep in at night, to stop my face sticking onto my pillows where it wept so much.

Kimberley felt very grateful for the support from her boyfriend, family and friends, but still felt mortified by her situation.

I was so embarrassed, I was completely mortified to be seen, she said.

If I went for a walk, I would just stare at the ground and never look anyone in the eye.

My boyfriend would always be so lovely. Whenever I started to feel bad, he would always bring me straight back up again.

In another attempt to clear her skin, in December 2020 Kimberley was prescribed a biologic an injection which targets the gene that causes inflammation which for three months cleared her skin.

Kimberley Reardon, 30, in September 2020 compared to now, with clear skin (Collect/PA Real Life)

I felt amazing, she said.

I was fatigued and achy from the side effects, but I felt so happy that something was working.

I had my first date night since 2019 at Frankie and Bennys with my boyfriend.

But, just as things were looking up, she developed a fungal infection across her arms and chest in February 2021.

It was so itchy. I was scratching so much I was ripping my skin off

She said: It was so itchy. I was scratching so much I was ripping my skin off.

So desperate to find something that worked, Kimberley even tried cryotherapy the use of extreme cold to freeze abnormal tissue for six weeks in July 2021.

She said: Once a week, I would stand in this freezing chamber, with temperatures at minus 110 to reduce inflammation.

It didnt work, it made me go purple, but I tried it as I was so desperate to do something and so scared of being bedbound again.

Just when she believed there was nothing else left to try, Kimberleys mum, Janey Reardon, 56, a retired receptionist, discovered the 9 cream in March this year.

Picking up a 30ml bottle for 8.99, she handed it to her daughter who cautiously applied some to a small patch on her finger.

She said: There had been no reaction in an hour, so I thought hopefully it would be okay.

I slathered it on and overnight and when I got up, my face was almost clear.

I couldnt believe it.

Using the cream every day, within one week, Kimberley was astounded to see that her skin was still miraculously clear.

And for the first time since 2019, she felt confident enough about her appearance to go to a coffee shop alone.

She said: I had a green tea in the coffee shop and for the first time in as long as I could remember, I wasnt worrying about people looking at my face.I had three date nights that week, one at the cinema and two foodie dates.

Even just going for a walk again was amazing.

Read the rest here:
Woman left balding and bedbound by chronic eczema clears the condition with a 9 face cream - The Independent

BARCELONA, Spain, June 7, 2022 /PRNewswire/ -- Almirall S.A. (BME: ALM) today announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, an investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Additionally, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period. These results build upon positive datafrom the 16-week, double-blind, placebo-controlled part of the ADvocate program.

"We are pleased to witness how lebrikizumab has proven over a year its potential to be a leading option for the treatment of atopic dermatitis. ADvocate 1 and 2 results add to the exciting, growing body of evidence from our Phase 3 clinical trial program and demonstrate that this medicine may provide much-needed relief for those seeking new treatment options. We look forward to continuing our collaboration with Lilly and advancing in our clinical program, aiming to obtain approval in the European Union," stated Karl Ziegelbauer, Ph.D., Almirall's Chief Scientific Officer.

AD, or atopic eczema, is a chronic, relapsing, heterogenous skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.1-2 Lebrikizumab is a novel, monoclonal antibody (mAb) that binds to the interleukin-13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13R1/IL-4R(Type 2 receptor) which blocks downstream signaling through the IL-13 pathway.3-7 IL-13 plays the central role in AD, promoting Type 2 inflammation that drives skin barrier dysfunction, itch, skin thickening and infection.8-10

In ADvocate 1, 79% of patients who received lebrikizumab every four weeks and 79% of patients who received lebrikizumab every two weeks maintained 75% or greater skin improvement (EASI-75) at one year of treatment. Additionally, 85% of patients who received lebrikizumab every four weeks and 77% of patients who received lebrikizumab every two weeks maintained EASI-75 response in ADvocate 2 at one year of treatment.

The frequency of adverse events and the overall safety profile among these patients treated with lebrikizumab were consistent with the induction phase of the trials as well as previous lebrikizumab studies in AD. No new safety signals were observed in this patient population.

"In these studies, patients treated with lebrikizumab maintained skin clearance and lasting relief from intense itch at one year. We look forward to providing an important new medicine and helping patients find the relief they so desperately seek from the varied and debilitating symptoms of this disease, contingent upon FDA approval," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Eli Lilly and Company.

With these data, Almirall plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lebrikizumab in AD in the second half of 2022. Lilly also plans to submit an application to the U.S. Food and Drug Administration (FDA) this year, followed by submissions to other regulatory agencies around the world.

These studies are part of the comprehensive clinical development program for lebrikizumab in AD evaluating more than 2,000 patients. Full one-year results from the Phase 3 monotherapy studies will be disclosed at upcoming congresses and in publications in 2022. Additional Phase 3 clinical trials are enrolling for lebrikizumab in AD.

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside Europe.

*EASI=Eczema Area and Severity Index, EASI-75=75 percent reduction in EASI from baseline to Week 16

About ADvocate 1 and ADvocate 2 and the Phase 3 Program

ADvocate 1andADvocate 2are 52-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 studies designed to evaluate lebrikizumab as monotherapy in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg) with moderate-to-severe AD.During the 16-week treatment period, patients received lebrikizumab 500-mg initially and at two weeks, followed by lebrikizumab 250-mg or placebo every two weeks. In the maintenance period, patients with moderate-to-severe AD who achieved a clinical response after 16 weeks of lebrikizumab treatment were re-randomized to receive lebrikizumab every two weeks or every four weeks or placebo for an additional 36 weeks.Patients who required rescue treatment during the induction period or who did not achieve clinical response (lebrikizumab non-responders) at 16 weeks received lebrikizumab every two weeks for an additional 36 weeks.The primary endpoints were measured by an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin with a reduction of at least two points from baseline and at least 75 percent change in baseline in the Eczema Area and Severity Index (EASI-75) score at 16 weeks. EASI measures extent and severity of the disease. Key secondary endpoints were measured by IGA, EASI, the Pruritus Numeric Rating Scale, Sleep-Loss due to Pruritus and the Dermatology Life Quality Index.

The U.S. Food and Drug Administration (FDA) granted lebrikizumab Fast Track designation in AD in December 2019. The lebrikizumab Phase 3 program consists of five key global studies including two monotherapy studies, a combination study (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies.

About Lebrikizumab

Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity to specifically prevent the formation of the IL-13R1/IL-4R heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is the central pathogenic mediator of AD, promoting Type 2 inflammation that drives skin barrier dysfunction, itch, skin thickening and infection.6-8

About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient's needs through science to improve their lives. Our Noble Purpose is at the core of our work: "Transform the patients' world by helping them realize their hopes and dreams for a healthy life". We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX35 (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros.

For more information, please visit almirall.com

Legal warning

This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law.

1Weidinger S, Novak N. Lancet. 2016;387:1109-1122.2Langan SM, et al. Arch Dermatol. 2008;142:1109.3Moyle M, et al. Exp Dermatol. 2019;28(7):756-768.4 Ultsch M, et al. J Mol Biol. 2013;425(8):1330-1339.5Zhu R, et al. Pulm Pharmacol Ther. 2017;46:88-98.6Simpson EL, et al. J Am Acad Dermatol. 2018;78(5):863-871.e11.7Okragly A, et al. Comparison of the Affinity and in vitro Activity of Lebrikizumab, Tralokinumab, and Cendakimab. Presented at the Inflammatory Skin Disease Summit, New York, November 3-6, 2021.8Tsoi L, et al. Journal of Investigative Dermatology. 2019;139(7):1480-1489.9Ratnarajah K, et al. Journal of Cutaneous Medicine and Surgery. 2021;25(3):315-328.10Bieber T. Allergy. 2020;75(1):54-62.

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SOURCE Almirall, S.A.

Originally posted here:
Almirall: Eight out of Ten Patients Maintained Skin Clearance at One Year in Lebrikizumab Atopic Dermatitis Monotherapy Trials - PR Newswire UK